Analysis of Urine & Body Fluids (Lesson 16) PDF

LESSON 16: Automation & Quality Assessment for AUBF Commission on Laboratory LECTURER: Ma’am Gemma Belarmino Assessment (COLA) OBJECTIVES:...

LESSON 16: Automation & Quality Assessment for AUBF Commission on Laboratory LECTURER: Ma’am Gemma Belarmino Assessment (COLA) OBJECTIVES: II. INTRODUCTION TO AUTOMATION 1. Define the different components of quality assessment in A. HISTORY AUBF. 2. Distinguish between components of internal QC, internal A1. ANCIENT HISTORY QC, electronic QC, and Proficiency Testing. 3. Explain the principles involved in the automated analysis Hippocrates of urine. 1st Urologist 4. Differentiate the manual, semi automated and fully Hypothesized that urine was a filtrate of 460 - 355 BC automated methods in the urine analysis. the humors. 5. Enumerate the advantages of automation in the analysis ○ Which came from the blood and was of urine. filtered through the kidneys. Galen TOPIC OUTLINE Refined Hippocrates' ideas. 1 Quality Assessment Theorized that urine represented not a 129 - 200 AD 2 Introduction to Automation filtrate of the four humors and overall 3 Principles Involved in Automation condition. 4 Implications in Automation ○ Rather, a filtrate of the blood. Theophilus Protospatharius I. QUALITY ASSESSMENT (QA) Wrote De Urinis. Guaranteeing quality patient care & regulated total testing 610 - 641 ○ A manuscript from Byzantium. system ○ The first publication exclusively on the subject of urine. A. QUALITY SYSTEM (QS) Johannes de Ketham of Germany Wrote Fasciculus Medicinae. 1491 Established a self-diagnostic color wheel to self-diagnose a disease using urine. A2. MODERN HISTORY Parisian chemist Jules Maumené (1818-1898). 1850 Developed the first "test strip" when he impregnated a strip of merino wool with tinprotochloride (stannous chloride). English physiologist George Oliver 1883 (1841-1915). Markets his Urinary Test Papers. Viennese chemist Fritz Feigl (1892-1971). 1920 ISO - International Organization for Standardization Published his technique of spot analysis. Urine test strips in the sense used today All laboratory's policies, procedures & resources needed 1950 were first made on an industrial scale in achieving quality testing. and offered commercially. Includes Quality Control (QC), Pre-examination, Examination, & Post Examination variables. The company Boehringer Mannheim, (now part of Roche). 1964 Specimen collection Launched its first Combur-Test strips Pre-examination Handling with new innovation. Variables Storage Aution Analyzer UA-6 by Arkray, Japan. Reagent status 1972 Launched the world's first automated Test Performance urine analyzer. Examination Instrument Calibration Variables Maintenance B. 3 WAYS TO PERFORM TEST STRIP ANALYSIS Personnel Requirements Technical Competence 1 Manual The test is done by hand. Reporting of results 2 Semi-automated Post Examination Interpretation The test strip is dipped in the urine manually and then Variables Turn around time analyzed by an instrument Documentation 3 Fully-automated Joint Commission (JC) Accreditation The test strip is analyzed completely by an instrument. College of American Pathologists Agencies (CAP) This transcript is strictly confidential and is intended for AVR 5TH FLOOR group members only; please don’t share or distribute! 1  ANALYSIS OF URINE & BODY FLUIDS | Lesson 16: Automation & Quality Assessment for AUBF B1. MANUAL Four week calibration stability Large LCD screen The test is done by hand. Touchscreen interface Operator software to access features like urine controls, data management, and customizable reporting. Simplicity 3 options for patient ID input: ○ Barcode ○ Manual Manual Procedure ○ Download from host PROCEDURE Easy cleaning Dip strip briefly, but completely into a well-mixed, room ○ one-step cleaning process 1 temperature urine sample. Proven Chemstrip technology 2 Withdraw strip. ○ Help avoid false negatives and 3 Blot briefly on its side. eliminate Vitamin C interference, which Keep the strip flat, read results at the appropriate times by can cause missed diagnoses. 4 comparing the color to the appropriate color on the chart ○ Test for SG, pH, leukocytes, nitrite, provided. protein, glucose, ketones, Accuracy urobilinogen, bilirubin, erythrocytes, B2. SEMI - AUTOMATED and color. Easy interface with LIS system The test strip is dipped in the urine manually and then ○ You can connect the instrument analyzed by an instrument. directly to your LIS system. Custom flags for results B3. FULLY - AUTOMATED The test strip is analyzed completely by an instrument. Automated urine cell analyzers mix, aspirate, dilute and stain urine to classify urine sediment particles​. Automated urine systems perform complete urine analysis that includes the physical, chemical and microscopic parts of a routine urinalysis​. DiaScreenSO Semi-Automated Urine Chemistry Analyzer PROCEDURE 1 Dip the reagent strip into a well-mixed urine sample. 2 Blot the strip to remove excess urine. 3 Place the strip onto the reagent strip platform. 4 Press the analyzer/enter button. iQ 200 Microscopy Analyzer COBAS U 411 URINE ANALYZER [VIDEO] - SEMI AUTOMATED Access the link below if you prefer watching it instead :)) Semi-automated Cobas U 411 Urine Analyzer Speed. Simplicity. Accuracy. Those are the essentials for a small to midsize that requires efficient, user-friendly processing of urine strips. This analyzer delivers with convenience that helps drive productivity. Diagram of the iQ 200 Digital Flow Capture Process COBAS U 411 URINE ANALYZER: KEY FEATURES 2 sensors detect the presence of a test AUTION HYBRID AU-4050 [VIDEO] strip automatically. - FULLY AUTOMATED This decreases handling and risk of Access the link below if you prefer watching it instead :)) operator error and allows for faster Fully Automated Aution Hybrid AU-4050 operation. Transform your laboratory operations with the Aution Hybrid Continuous strip loading Au-4050, a compact, fully automated, and integrated ○ No warmup time between strip loading urine analyzer that seamlessly combines two proven allows for batch processing of a new technologies. Speed strip every 6 seconds that’s up to 600 This innovative system excels in performing both urine test strips an hour. chemistry and sediment analysis within one small and Results in 60 seconds efficient package. ○ The system also prints out results AUTION HYBRID AU-4050: KEY FEATURES automatically, about 60 seconds after Total Minimizes labor-intensive manual steps. the strip is detected. Walk-Away Frees up operator time for more Stores hundreds (about 1300) of results. System valuable activities. ○ 1000 samples and 300 control tests. This transcript is strictly confidential and is intended for AVR 5TH FLOOR group members only; please don’t share or distribute! 2  ANALYSIS OF URINE & BODY FLUIDS | Lesson 16: Automation & Quality Assessment for AUBF Easy-to-use analyzer with one-step AUTOMATED ANALYZERS IN THE MARKET loading of trusted Aution dry pad urine User-Friendly chemistry test strips. Operation No calibration required, streamlining the workflow. Aspirates the sample and precisely dispenses urine on each pad during analysis. Arkray Urine Analyzer by ARKRAY, Inc.​ Iris Analyzer by Beckman Coulter​ The module measures 9 chemistries: ○ Glucose ○ Protein ○ Bilirubin ○ Urobilinogen ○ pH Chemistry ○ Blood Module ○ Ketones ○ Nitrites Cobas u6500 by Roche Diagnostics ○ Leukocytes Clinitek Novus by Siemens​ For improved accuracy, the color compensation pad accounts for III. PRINCIPLES OF AUTOMATION normal urine colors and the abnormal A. PHOTOMETRY color detection notifies users for false positive reactions. It also performs specific gravity and color and turbidity measurements. Flow Cytometry User-defined criteria advance the Module sample to this module. Heated at 35°C to remove amorphous urates. “Measurement of light” Urine sample is mixed with diluent and Substance is converted to a soluble, colored material, its fluorescent stain to accurately detect concentration is determined by the amount of color and enumerate formed elements (RBCs, present in the solution.​ WBCs, epithelial cells, and casts). Photometer & Spectrophotometer are instruments used Sediment The analyzer also flags 6 additional ​for this type of measurement​. Chamber elements for review. The combination of urine chemistry and B. REFLECTANCE PHOTOMETRY sediment analysis technology generates standardized and accurate results in one consolidated report, providing operator confidence time after time. Mixes the urine sample with diluent and nucleic acid stain and is heated at Bacteria 42°C to suppress nonspecific staining. Chamber Coupled with anti-carry-over rinse for uncompromised bacterial discrimination. Utilize instrument parameters to create effective reflex culture criteria, Multi-layer Thin Film Dry Slide Technology​ Reflex Culture minimizing time and costs associated Criteria Uses the principle that light reflection from the test pads with reviewing contaminated or negative decreases in proportion to the intensity of color produced urine cultures. by the concentration of the test substance.​ Processes up to 200 chemistry samples A monochromatic light source is directed toward the High Capacity per hour. reagent pads.​ System Delivers rapid results in as little as 2 The light is reflected to a photodetector and an minutes and 15 seconds. analog/digital converter.​ Ideal fit for laboratories of all sizes and Compare the amount of light reflection with that of known Compact Size volumes, meeting space constraints. concentration.​ Proven Aution Hybrid AU-4050 combines Technology, proven technologies to achieve the Trusted Results quality results expected by operators. Disclaimer: ARKRAY recommends the use of proper protective attire critical for laboratory safety when running samples. Product availability varies by country. This transcript is strictly confidential and is intended for AVR 5TH FLOOR group members only; please don’t share or distribute! 3  ANALYSIS OF URINE & BODY FLUIDS | Lesson 16: Automation & Quality Assessment for AUBF C. TURBIDITY Refractometer is the instrument used to measure refractive index​. Measures the extent to which light is bent when it moves from air into a sample​. Refraction Index: ratio of the speed of light in a vacuum to the speed of light in another substance​. F. LASER FLOW CYTOMETRY Principle of Turbidimetry Measurement of ↓decrease in light transmitter through a turbid solution is measured.​ ​Turbidity is a measure of suspended solids concentration.​ Contains dissolved molecules and ion ○ May not be turbid but can be colored.​ D. LIGHT TRANSMISSION/ LIGHT SCATTER Laser Flow Cytometry Utilizes 2 stains with fluorescent dyes to stain cellular elements​. Separate bacteria channel for improved discrimination​. TO IDENTIFY URINE SEDIMENT PARTICLES: 1 Forward scatter 2 Hydrodynamic focusing 3 Forward fluorescent light 4 Conductivity measurements Light Transmission/ Light Scatter 5 Adaptive Cluster analysis Amount of light scattered or reflected is directly G. PRINCIPLES OF URINE SEDIMENT ANALYZERS proportional to the product of the polymer molar mass & concentration.​ Identification of the stained urine sediment. Mie Theory ○ Angular variation of the scattered light is directly G1. FLOW CYTOMETRY (proportional) to the size of the molecule EDITOR’S NOTE: Ms. Belarmino’s ppt only says “directly” in Mie Theory, but it makes more sense to say “directly proportional.” FACTORS INFLUENCING LIGHT SCATTER: 1 Particle size 4 Wavelength dependence Concentration of Effect of polarization of 2 5 particles incident light Molecular weight of 3 6 Distance of observation particles Flow Cytometer E. REFRACTOMETRY MEASURES: 1 Forward light scatter​ 2 Side scatter​ 3 Fluorescence staining characteristic​ 4 Adaptive Cluster analysis Refractometry Method of measuring substances refractive index​. This transcript is strictly confidential and is intended for AVR 5TH FLOOR group members only; please don’t share or distribute! 4  ANALYSIS OF URINE & BODY FLUIDS | Lesson 16: Automation & Quality Assessment for AUBF UF-1000i DETECTION PARAMETERS ENUMERATED FLAGGED PARAMETERS PARAMETERS RBC Pathological Casts WBC Crystals Epithelial Cells Small Round Cells Hyaline Casts Yeast Mucus Bacteria Sperm Flow Cytometer G1.1. FLH / FSC - SCATTERGRAM Flow Cytometer Flow Cytometry MEASURES: 1 Forward Scatter (FSC) ADDITIONAL NOTES: [CHATGPT] 2 Fluorescence High (FLH)​ Axes: 3 Fluorescence Low (FLL) 1. X-axis (FLH): Represents fluorescence intensity, 4 Fluorescence Low Width 2 (FLLW2) usually related to the presence of specific markers or 5 Fluorescence Low Width (FLLW) stains on the particles being analyzed. 6 Side Scatter (SSC) 2. Y-axis (FSC): Represents the forward scatter, which 7 Forward Scatter Width (FSCW) correlates with the size of the particles. Regions and Populations: 1. Bacteria (bottom-left): ○ Very small size with low fluorescence. ○ Typical for microorganisms like bacteria. 2. RBCs (red region): ○ Small to medium size with low fluorescence. ○ Likely representing red blood cells, which lack a nucleus and therefore exhibit low fluorescence. 3. XTAL (crystals): ○ A group with small to large size and low fluorescence. ○ Represents possible crystalline structures or debris. 4. YLC (yeast-like cells): ○ Small to medium size with low fluorescence. ○ Can include fungal elements. 5. Sperm (green region): ○ Small size with moderate fluorescence. ○ These cells have distinctive fluorescence due to DNA or other markers. 6. WBCs (blue region): ○ Medium to large size with moderate to high fluorescence. ○ White blood cells (WBCs) are larger and have internal complexity, contributing to higher fluorescence. Identification of the stained Urine Sediment This transcript is strictly confidential and is intended for AVR 5TH FLOOR group members only; please don’t share or distribute! 5  ANALYSIS OF URINE & BODY FLUIDS | Lesson 16: Automation & Quality Assessment for AUBF G1.2. SCATTERGRAMS: SYSMEX UF1000i FULLY AUTOMATED URINE MICROSCOPY ANALYSERS: MODEL MANUFACTURERS UF- 1000i Urine Cell Sysmex Corporation Analyzer iQ 200 Automated Urine Microscopy Iris diagnostics iQ 200 Sprint FULLY AUTOMATED URINE ANALYSER SYSTEMS: MODEL MANUFACTURERS iRICELL Urinalysis System Iris diagnostics Siemens Healthcare CLINITEK AUWI System Diagnostics, Inc. BODY FLUID ANALYSER SYSTEMS MODEL MANUFACTURERS Flow Cytometry iQ200 using Body Fluids Iris diagnostics IV. PRINCIPLES IN AUTOMATION Software ADVIA 2120i with Body Siemens Healthcare A. MEASUREMENT TECHNOLOGY METHODS Fluids Software Diagnostics, Inc. MEASUREMENT TECHNOLOGY METHODS Sysmex XE-5000 using Body Sysmex Corporation Fluids mode Manufacturer Color Clarity Specific Gravity V. IMPLICATIONS OF AUTOMATION Arkay, Inc. Photometry Light Scatter Refractive Index FOR STANDARDIZATION OF: Light Light 1 Sample processing Iris Transmission Transmission 2 Biochemical test strips analysis Refractive Index Diagnostics / Light / Light 3 Microscopy analysis Scatter Scatter 4 Reporting of results Roche Reflectance Turbidity Refractometry Diagnostics photometry FEATURES OF AUTOMATED URINE ANALYZERS Siemens Light 1 On-line computer capability Healthcare Reflectance Transmission 2 Bar coding Refractive Index 3 Manual entry of color Diagnostics, photometry / Light Inc. Scatter 4 Clarity 5 Microscopic results B. URINALYSIS AUTOMATION 6 Flagging of abnormal results 7 Sorting of patients and control results SEMI-AUTOMATED URINE CHEMISTRY ANALYSERS 8 Minimal calibration MODEL MANUFACTURERS 9 Autocleaning Clinitek Advantus​ 10 Scheduled maintenance Siemens Healthcare Clinitek Status​ Diagnostics, Inc.​ DISADVANTAGES OF MANUAL METHOD: Urisys 1800 system​ 1 Subjective color reading Roche Diagnostics​ 2 Subjective element identification COBAS u411​ 3 Poor reproducibility DiaScreen 50​ U.S Arkray​ 4 Lack of standardization iChem 100​ Iris Diagnostics​ 5 Time consuming / Labor intensive FULLY AUTOMATED URINE CHEMISTRY ANALYSERS: REFERENCES: MODEL MANUFACTURERS 1 S.K. Strasinger, Urinalysis and Body Fluids, 6th Ed N, Brunzel, Fundamentals of Urine and Body Fluids Siemens Healthcare 2 Clinitek Atlas Analysis, 4th Ed Diagnostics, Inc. Henry's Clinical Diagnosis and Management by Urisys 2400 System Roche diagnostics 3 Laboratory Methods, 22nd Ed Aution Max AX-4300 U.S. Arkway iChem Velocity Iris Diagnostics This transcript is strictly confidential and is intended for AVR 5TH FLOOR group members only; please don’t share or distribute! 6